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临床试验/NCT01627509
NCT01627509Unknown不适用

Comparison of Modern Premixed Insulin and Basal-Bolus Regimens on Blood Glucose Control Using CGMS Device in Optimally-controlled Subjects With DM2.

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2

研究概览

简要总结

Intensive Insulin Therapy (IIT) may be given in Type 2 Diabetes (T2DM) in two different ways :

  • as Basal/bolus therapy (B/B) in four-five injections per day .
  • as Modern Premixed Insulins( MPI's) three times per day . The better diabetes control is achieved, the more likely patient would suffer from hypoglycemic episodes. We propose that the probability of hypoglycemia and its severity has no difference in two main insulin therapy schemes mentioned above.

The objective of the study is to compare the incidence of hypoglycemia and its severity in well-controlled ( HBA1C less than 7%) diabetic individuals treated by two different regimens, through analysis of data received by Continuous Glucose Monitoring (CGM, Free Style Navigator).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetes Mellitus Type 2 diagnosis confirmed by endocrinologist.
  • Diabetes Mellitus Type 2 history of one year at least.
  • HAb1C < 7% and less
  • Age 18-80 yrs
  • Normal Liver function tests

排除标准

  • History of substance use
  • Pregnancy or breastfeeding mothers
  • Abnormal liver or kidney functional tests
  • Type 1 Diabetes or LADA
  • any active disease ( like viral) at the period of investigation

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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